To Observe the CD7-targeted CAR-T Therapy in the Treatment of MRD Positive T-ALL/LBL Post Allo-HSCT

NCT07280494 | Recruiting Phase 1

• 1 other identifier: Anti CD7 CAR-T for MRD+ T-ALL
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of T-lymphoblastic leukaemia/lymphoma with postive measurable residual disease positive post allogeneic stem cell transplantation

Conditions

CD7+ T-ALL/LBL

Keywords

CD7; CAR T cell therapy; T-lymphoblastic leukemia/lymphoma; measurable residual disease; allogeneic hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• +1m MRD negtaive rate

  The MRD negative rate post CAR-T infusion

  28 days post CAR-T infusion

Secondary Outcomes (6)

• +2m MRD negative rate

  at 2 months post CAR-T infusion

• +3m MRD negative rate

  at 3 months post CAR-T infusion

• survival

  at 1 year post CAR-T infusion

• relapse

  at 1 year post CAR-T infusion

• GVHD

  1 year post CAR-T infusion

Study Arms (1)

anti CD7 CAR-T cells therapy

EXPERIMENTAL

eligible patients will be treated with CD7-targeted CAR-T cells

Drug: CAR-T Therapy

Interventions

CAR-T Therapy DRUG

autologous or donor-derived CD7-targeted CAR-T cells, single injection

anti CD7 CAR-T cells therapy

Eligibility Criteria

• Age: 3 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) The subject or the legal guardian understands and voluntarily signs the informed consent form (ICF).
• (2) Male or female, age ≥ 3 years at the time of signing the informed consent form.
• (3) Expected survival period of no less than 12 weeks. (4) ECOG performance score of 0-2 at the time of signing the ICF. (5) Confirmed as relapsed/refractory T-cell leukemia or lymphoma at the time of signing the ICF, meeting the following criteria:
• Bone marrow morphology examination at screening shows the proportion of primitive immature lymphocytes in the bone marrow \< 5%, and positive for minimal residual disease of leukemia/lymphoma determined by flow cytometry.
• Tumor cells in the bone marrow or peripheral blood are CD7 positive as detected by flow cytometry.
• (6) Major organ functions must meet the following requirements:
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• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5× upper limit of normal (ULN).
• Total bilirubin ≤ 2× ULN.
• For adult subjects, the serum creatinine clearance rate ≥ 60 mL/min (Cockcroft-Gault formula) or serum creatinine ≤ 1.5× ULN; for children, the serum creatinine should be no more than 0.8 mg/dL for 2 to 6 years old, 1.0 mg/dL for 6 to 10 years old, 1.2 mg/dL for 10 to 13 years old, 1.5 mg/dL for 13 to 16 years old males, and 1.4 mg/dL for females over 13 years old; for males over 16 years old, it should be no more than 1.7 mg/dL.
• If the above organ function abnormalities are caused by infiltration of the primary disease, the decision on whether to include the subject in the study is made by the investigator.
• (7) Blood oxygen saturation \> 92%. (8) Male subjects with reproductive capacity and female subjects of childbearing age must agree to use effective contraceptive measures from the time of signing the informed consent form until 2 years after the use of the study drug. Female subjects of childbearing age include premenopausal women and women within 2 years after menopause. The blood pregnancy test of female subjects of childbearing age at screening must be negative.

You may not qualify if:

• A history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and neuropathy. A history of diseases without related neurological symptoms before screening, such as lacunar infarction, etc., will be excluded at the discretion of the investigator.
• Any uncontrolled active infection within 4 weeks before signing the ICF or before apheresis.
• Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening and peripheral blood hepatitis B virus (HBV) DNA above the detection limit, positive hepatitis C virus (HCV) antibody and positive HCV RNA, positive human immunodeficiency virus (HIV) antibody, cytomegalovirus (CMV) DNA above the detection limit, Epstein-Barr virus (EBV) DNA above the detection limit, and both specific and non-specific antibodies for Treponema pallidum positive need to be excluded.
• Clinically significant cardiovascular diseases, including any of the following:
• Corrected QTc interval ≥ 480 ms (QTc interval calculated by the Fridericia formula);
• New York Heart Association (NYHA) class II or higher heart failure;
• Unstable angina or acute myocardial infarction within 6 months before signing the ICF;
• Left ventricular ejection fraction (LVEF) \< 50%;
• Uncontrolled hypertension (judged by the investigator based on the individual condition of the subject);
• Clinically significant or requiring antiarrhythmic treatment arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, and complete left bundle branch block, etc.).
• Allergy to any component of the drugs to be used in this study.
• Received any investigational drug treatment or other systemic anti-tumor treatment within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is judged more appropriate by the investigator), except for bridging chemotherapy due to large tumor burden or rapid disease progression.
• Received extensive radiotherapy within 4 weeks before signing the ICF, except for local radiotherapy for symptom relief of non-target lesions during the study period.
• Received systemic corticosteroids (dose equivalent to or higher than 10 mg/day of prednisone) or other immunosuppressive drugs within 3 days before apheresis or during the study period, except for the following situations:
• Intranasal, inhaled, topical steroids or local steroid injections (such as intra-articular injections);

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China, 100044, China

RECRUITING

MeSH Terms

Conditions

Lymphoma; Neoplasm, Residual

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Xiaojun Huang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Liu

CONTACT

8610-88326900; greenimp@163.com

Na Kuang

CONTACT

86-18630160116; kuangna@senlangbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Model Details: A single group of patients receives a dose of 2e6 cells/kg NS CD7-targeted cell therapy.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

CN (1)